A Comparison Between Primary and Secondary Flap Coverage in Extraction Sites: A Pilot Study

NCT03136913 | Completed Results FDA Device

• 1 other identifier: 11441
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to compare the outcomes of two separate surgical techniques used in tooth extraction and ridge preservation. Ridge preservation is done to potentially minimize the amount of bone loss that occurs between the tooth extraction and implant or bridge placement, as compared to leaving the extraction site empty. There are two techniques that are commonly used for these procedures, either to close the surgical site of the extracted tooth with sutures (closed flap technique) or to leave the extraction site open to heal naturally (open flap technique). In the open flap technique there will be sutures used to secure and hold down the material used to cover the wound, called a non-resorbable membrane. The flaps will remain in their natural position, the site will fill up naturally with new tissue from the bottom up and then close itself in from the sides. The investigators want to see which technique offers better healing and reduces bone loss.

Conditions

Loss of Teeth Due to Extraction

Outcome Measures

Primary Outcomes (1)

• Mean Difference in Alveolar Bone Height Change

  Models/casts will be made in stone using the impressions. A stent will be made to measure the height and width of the alveolar ridge. Ridge height will be measured before tooth extraction, and 3-5 months after ridge preservation.

  < 6 months post extraction and ridge preservation

Secondary Outcomes (2)

• Post-operative Pain/Discomfort

  Up to 16 days post extraction and ridge preservation

• Percentage New Bone Formation

  Up to 6 months post extraction and ridge preservation

Study Arms (2)

Closed Flap Technique

ACTIVE COMPARATOR

Healing by primary intention: Extraction and ridge preservation, utilizing non-resorbable membrane (Cytoplast® TXT-200 ) and freeze dried bone allograft (MinerOss® Cortical and Cancellous Chips (FDBA)), with flaps in primary coverage.

Device: Cytoplast® TXT-200; Device: MinerOss® Cortical and Cancellous Chips (FDBA); Procedure: Closed Flap Technique

Open Flap Technique

ACTIVE COMPARATOR

Healing by secondary intention: Extraction and ridge preservation, utilizing non-resorbable membrane (Cytoplast® TXT-200) and freeze dried bone allograft (MinerOss® Cortical and Cancellous Chips (FDBA)), with flaps in position for healing by secondary intention.

Device: Cytoplast® TXT-200; Device: MinerOss® Cortical and Cancellous Chips (FDBA); Procedure: Open Flap Technique

Interventions

Cytoplast® TXT-200 DEVICE

Non-resorbable membrane

Closed Flap Technique; Open Flap Technique

MinerOss® Cortical and Cancellous Chips (FDBA) DEVICE

Mixture of allograft mineralized cortical and cancellous chips

Closed Flap Technique; Open Flap Technique

Open Flap Technique PROCEDURE

After extraction, the socket wound is left open to heal by secondary intention

Open Flap Technique

Closed Flap Technique PROCEDURE

After extraction, the socket wound is closed by primary closure

Closed Flap Technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient who is treatment planned at Tufts University School of Dental Medicine (TUSDM) for extraction and future implant placement and meet all medical and dental requirements of the TUSDM periodontology clinic for periodontal surgery (e.g., subjects with no diseases or medication allergies contraindicating periodontal surgery).
• Patient must have bilateral extraction (canine to molar) sites of teeth located on the same arch (e.g. upper right and upper left) treatment planned for future implant placement at TUSDM.
• The number of teeth planned for extraction (either one or two adjacent) and ridge preservation should match the same number of teeth (either one or two adjacent) from the contra-lateral side on the same arch.
• Presence of at least 3 intact bony walls and at least half of the fourth bony wall at each site as determined by bone sounding at Visit 1.

You may not qualify if:

• Have any known disease that interferes with periodontal surgery and would not allow the patient to be treatment planned for the procedures in the TUSDM periodontology clinic (e.g., severe anemia, low white blood cell count, bleeding or coagulation disorder, uncontrolled hypertension (150/90), recent myocardial infarction (within 6 months of enrollment), diabetes (HbA1C ≥7%), HIV/AIDS (self-reported), history of or currently undergoing head and neck radiation, history of or currently taking bisphosphonates).
• Subject who has a disease or condition that may affect hard and soft tissue healing (e.g., previous or current head and neck radiation therapy, long term steroid use defined as more than two weeks in the past two years).
• Subject who has diseases that affect bone metabolism (e.g., osteoporosis, osteopenia).
• Pregnancy (self-reported)
• Current Smokers
• Extraction socket with \> 50% bone loss on the buccal or lingual/palatal bone as determined by bone sounding at Visit 1.
• Allergic to gentamycin, povidone-iodine, or surfactants as trace amounts may be contained in the MinerOss®

Sponsors & Collaborators

• Tufts University: lead

Study Sites (1)

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

Related Publications (2)

• Aladmawy MA, Natto ZS, Kreitzer M, Ogata Y, Hur Y. Histological and histomorphometric evaluation of alveolar ridge preservation using an allograft and nonresorbable membrane with and without primary closure: A pilot randomized controlled clinical trial. Medicine (Baltimore). 2022 Jul 1;101(26):e29769. doi: 10.1097/MD.0000000000029769.

  PMID: 35777057 DERIVED

• Aladmawy MA, Natto ZS, Steffensen B, Levi P, Cheung W, Finkelman M, Ogata Y, Hur Y. A Comparison between Primary and Secondary Flap Coverage in Ridge Preservation Procedures: A Pilot Randomized Controlled Clinical Trial. Biomed Res Int. 2019 Aug 20;2019:7679319. doi: 10.1155/2019/7679319. eCollection 2019.

  PMID: 31531367 DERIVED

Results Point of Contact

• Title: Dr. Yong Hur
• Organization: Tufts University

Yong.Hur@tufts.edu

6176366531

Study Officials

• Yong Hur, DMD, MSc

  TUSDM

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 2, 2017
• Study Start: February 17, 2015
• Primary Completion: April 1, 2016
• Study Completion: October 11, 2016
• Last Updated: August 12, 2021
• Results First Posted: August 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)